Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this project is to evaluate the level of mitochondrial dysfunction several patient populations: Burn, trauma, and control group of healthy volunteers. Study hypothesis: Increased plasma concentrations of a newly discovered inflammatory mediated, called mtDNA DAMPS associated with the occurrence of multi-organ dysfunction syndrome in severly injured patients. As the severity of a burn injury or trauma injury increase, so will systemic mitochondrial dysfunction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 13, 2013
CompletedFirst Posted
Study publicly available on registry
March 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedMay 28, 2021
May 1, 2021
10.3 years
March 13, 2013
May 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma mtDNA DAMPs concentration
Plasma mtDNA DAMPs concentration
approximately 1 year to assess outcome measure
Study Arms (3)
Burn: blood collection
OTHERProcedure: Blood draws as the intervention.
trauma: blood collection
OTHERblood to be collected at different time intervals. Blood draw as the intervention
healthy volunteers: blood collection
OTHERBlood draws as the intervention
Interventions
Blood samples collected at certain timepoints. Time points for burn/trauma subjects: Day0,Day1,Day2,and Day6 and Day7.
blood collected at designated time intervals
Eligibility Criteria
You may qualify if:
- Burn injury must be less than 24 hours old at time of initial sampling
- Burn must be 2nd or 3rd degree and at least 10% TBSA
- ISS (injury severity score) \> 15
You may not qualify if:
- Burn injury/trauma injury \> than 24hours old at time of initial sampling
- Burn \< 10% total body surface area.
- Evidence of active infection on admission in the burn subjects.
- \< 19 years of age and \> 70 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of South Alabama Medical Center
Mobile, Alabama, 36617, United States
Related Publications (1)
Simmons JD, Lee YL, Mulekar S, Kuck JL, Brevard SB, Gonzalez RP, Gillespie MN, Richards WO. Elevated levels of plasma mitochondrial DNA DAMPs are linked to clinical outcome in severely injured human subjects. Ann Surg. 2013 Oct;258(4):591-6; discussion 596-8. doi: 10.1097/SLA.0b013e3182a4ea46.
PMID: 23979273DERIVED
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Jon Simmons, MD
University of South Alabama, Department of Surgery
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
March 13, 2013
First Posted
March 18, 2013
Study Start
September 1, 2011
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
May 28, 2021
Record last verified: 2021-05